Clinical trial NCT01123486 - References

Pain — Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint

Citation(s)

•   Angst MS, Chu LF, Tingle MS, Shafer SL, Clark JD, Drover DR
  No evidence for the development of acute tolerance to analgesic, respiratory depressant and sedative opioid effects in humans. Pain. 2009 Mar;142(1-2):17-26. doi: 10.1016/j.pain.2008.11.001. Epub 2009 Jan 9.
•   Ausems ME, Hug CC Jr, Stanski DR, Burm AG
  Plasma concentrations of alfentanil required to supplement nitrous oxide anesthesia for general surgery. Anesthesiology. 1986 Oct;65(4):362-73.
•   Ausems ME, Vuyk J, Hug CC Jr, Stanski DR
  Comparison of a computer-assisted infusion versus intermittent bolus administration of alfentanil as a supplement to nitrous oxide for lower abdominal surgery. Anesthesiology. 1988 Jun;68(6):851-61.
•   Baririan N, Van Obbergh L, Desager JP, Verbeeck RK, Wallemacq P, Starkel P, Horsmans Y
  Alfentanil-induced miosis as a surrogate measure of alfentanil pharmacokinetics in patients with mild and moderate liver cirrhosis. Clin Pharmacokinet. 2007;46(3):261-70.
•   Barrett PH, Bell BM, Cobelli C, Golde H, Schumitzky A, Vicini P, Foster DM
  SAAM II: Simulation, Analysis, and Modeling Software for tracer and pharmacokinetic studies. Metabolism. 1998 Apr;47(4):484-92.
•   Billard V, Gambus PL, Chamoun N, Stanski DR, Shafer SL
  A comparison of spectral edge, delta power, and bispectral index as EEG measures of alfentanil, propofol, and midazolam drug effect. Clin Pharmacol Ther. 1997 Jan;61(1):45-58.
•   Björkman S, Wada DR, Stanski DR, Ebling WF
  Comparative physiological pharmacokinetics of fentanyl and alfentanil in rats and humans based on parametric single-tissue models. J Pharmacokinet Biopharm. 1994 Oct;22(5):381-410. Erratum in: J Pharmacokinet Biopharm 1995 Aug;23(4):438.
•   Bouillon T, Bruhn J, Radu-Radulescu L, Andresen C, Cohane C, Shafer SL
  A model of the ventilatory depressant potency of remifentanil in the non-steady state. Anesthesiology. 2003 Oct;99(4):779-87.
•   Coda B, Tanaka A, Jacobson RC, Donaldson G, Chapman CR
  Hydromorphone analgesia after intravenous bolus administration. Pain. 1997 May;71(1):41-8.
•   Dahan A, Romberg R, Teppema L, Sarton E, Bijl H, Olofsen E
  Simultaneous measurement and integrated analysis of analgesia and respiration after an intravenous morphine infusion. Anesthesiology. 2004 Nov;101(5):1201-9.
•   Davis JJ, Swenson JD, Hall RH, Dillon JD, Johnson KB, Egan TD, Pace NL, Niu SY
  Preoperative "fentanyl challenge" as a tool to estimate postoperative opioid dosing in chronic opioid-consuming patients. Anesth Analg. 2005 Aug;101(2):389-95, table of contents. Erratum in: Anesth Analg. 2005 Oct;101(4):965.
•   Dershwitz M, Walsh JL, Morishige RJ, Connors PM, Rubsamen RM, Shafer SL, Rosow CE
  Pharmacokinetics and pharmacodynamics of inhaled versus intravenous morphine in healthy volunteers. Anesthesiology. 2000 Sep;93(3):619-28.
•   Ebling WF, Lee EN, Stanski DR
  Understanding pharmacokinetics and pharmacodynamics through computer stimulation: I. The comparative clinical profiles of fentanyl and alfentanil. Anesthesiology. 1990 Apr;72(4):650-8.
•   Egan TD, Lemmens HJ, Fiset P, Hermann DJ, Muir KT, Stanski DR, Shafer SL
  The pharmacokinetics of the new short-acting opioid remifentanil (GI87084B) in healthy adult male volunteers. Anesthesiology. 1993 Nov;79(5):881-92.
•   Egan TD, Minto CF, Hermann DJ, Barr J, Muir KT, Shafer SL
  Remifentanil versus alfentanil: comparative pharmacokinetics and pharmacodynamics in healthy adult male volunteers. Anesthesiology. 1996 Apr;84(4):821-33. Erratum in: Anesthesiology 1996 Sep;85(3):695.
•   Fiset P, Mathers L, Engstrom R, Fitzgerald D, Brand SC, Hsu F, Shafer SL
  Pharmacokinetics of computer-controlled alfentanil administration in children undergoing cardiac surgery. Anesthesiology. 1995 Nov;83(5):944-55.
•   Gourlay GK, Wilson PR, Glynn CJ
  Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67.
•   Gregg KM, Varvel JR, Shafer SL
  Application of semilinear canonical correlation to the measurement of opioid drug effect. J Pharmacokinet Biopharm. 1992 Dec;20(6):611-35.
•   Hughes MA, Glass PS, Jacobs JR
  Context-sensitive half-time in multicompartment pharmacokinetic models for intravenous anesthetic drugs. Anesthesiology. 1992 Mar;76(3):334-41.
•   Kern SE, Stanski DR
  Pharmacokinetics and pharmacodynamics of intravenously administered anesthetic drugs: concepts and lessons for drug development. Clin Pharmacol Ther. 2008 Jul;84(1):153-7. doi: 10.1038/clpt.2008.80. Epub 2008 May 7. Review.
•   Kharasch ED, Hoffer C, Walker A, Sheffels P
  Disposition and miotic effects of oral alfentanil: a potential noninvasive probe for first-pass cytochrome P4503A activity. Clin Pharmacol Ther. 2003 Mar;73(3):199-208.
•   Kharasch ED, Walker A, Hoffer C, Sheffels P
  Intravenous and oral alfentanil as in vivo probes for hepatic and first-pass cytochrome P450 3A activity: noninvasive assessment by use of pupillary miosis. Clin Pharmacol Ther. 2004 Nov;76(5):452-66.
•   Kuipers JA, Boer F, Olofsen E, Bovill JG, Burm AG
  Recirculatory pharmacokinetics and pharmacodynamics of rocuronium in patients: the influence of cardiac output. Anesthesiology. 2001 Jan;94(1):47-55.
•   Lemmens HJ, Dyck JB, Shafer SL, Stanski DR
  Pharmacokinetic-pharmacodynamic modeling in drug development: application to the investigational opioid trefentanil. Clin Pharmacol Ther. 1994 Sep;56(3):261-71.
•   Lemmens HJ, Egan TD, Fiset P, Stanski DR
  Pharmacokinetic/dynamic assessment in drug development: application to the investigational opioid mirfentanil. Anesth Analg. 1995 Jun;80(6):1206-11.
•   Maitre PO, Ausems ME, Vozeh S, Stanski DR
  Evaluating the accuracy of using population pharmacokinetic data to predict plasma concentrations of alfentanil. Anesthesiology. 1988 Jan;68(1):59-67.
•   Maitre PO, Stanski DR
  Bayesian forecasting improves the prediction of intraoperative plasma concentrations of alfentanil. Anesthesiology. 1988 Nov;69(5):652-9.
•   Maitre PO, Vozeh S, Heykants J, Thomson DA, Stanski DR
  Population pharmacokinetics of alfentanil: the average dose-plasma concentration relationship and interindividual variability in patients. Anesthesiology. 1987 Jan;66(1):3-12.
•   Manyam SC, Gupta DK, Johnson KB, White JL, Pace NL, Westenskow DR, Egan TD
  Opioid-volatile anesthetic synergy: a response surface model with remifentanil and sevoflurane as prototypes. Anesthesiology. 2006 Aug;105(2):267-78.
•   Manyam SC, Gupta DK, Johnson KB, White JL, Pace NL, Westenskow DR, Egan TD
  When is a bispectral index of 60 too low?: Rational processed electroencephalographic targets are dependent on the sedative-opioid ratio. Anesthesiology. 2007 Mar;106(3):472-83.
•   Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL
  Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23.
•   Minto CF, Schnider TW, Shafer SL
  Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.
•   Phimmasone S, Kharasch ED
  A pilot evaluation of alfentanil-induced miosis as a noninvasive probe for hepatic cytochrome P450 3A4 (CYP3A4) activity in humans. Clin Pharmacol Ther. 2001 Dec;70(6):505-17.
•   Raemer DB, Buschman A, Varvel JR, Philip BK, Johnson MD, Stein DA, Shafer SL
  The prospective use of population pharmacokinetics in a computer-driven infusion system for alfentanil. Anesthesiology. 1990 Jul;73(1):66-72. Erratum in: Anesthesiology 1990 Oct;73(4):798.
•   Scott JC, Cooke JE, Stanski DR
  Electroencephalographic quantitation of opioid effect: comparative pharmacodynamics of fentanyl and sufentanil. Anesthesiology. 1991 Jan;74(1):34-42.
•   Scott JC, Ponganis KV, Stanski DR
  EEG quantitation of narcotic effect: the comparative pharmacodynamics of fentanyl and alfentanil. Anesthesiology. 1985 Mar;62(3):234-41.
•   Scott JC, Stanski DR
  Decreased fentanyl and alfentanil dose requirements with age. A simultaneous pharmacokinetic and pharmacodynamic evaluation. J Pharmacol Exp Ther. 1987 Jan;240(1):159-66.
•   Segre G
  Kinetics of interaction between drugs and biological systems. Farmaco Sci. 1968 Oct;23(10):907-18.
•   Shafer SL, Gregg KM
  Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump. J Pharmacokinet Biopharm. 1992 Apr;20(2):147-69.
•   Shafer SL, Stanski DR
  Improving the clinical utility of anesthetic drug pharmacokinetics. Anesthesiology. 1992 Mar;76(3):327-30.
•   Shafer SL, Varvel JR, Aziz N, Scott JC
  Pharmacokinetics of fentanyl administered by computer-controlled infusion pump. Anesthesiology. 1990 Dec;73(6):1091-102.
•   Shafer SL, Varvel JR
  Pharmacokinetics, pharmacodynamics, and rational opioid selection. Anesthesiology. 1991 Jan;74(1):53-63.
•   Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J
  Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther. 1979 Mar;25(3):358-71.
•   Stanski DR, Hug CC Jr
  Alfentanil--a kinetically predictable narcotic analgesic. Anesthesiology. 1982 Dec;57(6):435-8.
•   Upton RN, Semple TJ, Macintyre PE
  Pharmacokinetic optimisation of opioid treatment in acute pain therapy. Clin Pharmacokinet. 1997 Sep;33(3):225-44. Review.
•   Vuyk J, Lim T, Engbers FH, Burm AG, Vletter AA, Bovill JG
  Pharmacodynamics of alfentanil as a supplement to propofol or nitrous oxide for lower abdominal surgery in female patients. Anesthesiology. 1993 Jun;78(6):1036-45; discussion 23A.

A Hydromorphone High Resolution Pharmacokinetic-Pharmacodynamic Fingerprint as the Basis for Identifying Sex Differences in Opioid Pharmacokinetics and Pharmacodynamics

Details for clinical trial NCT01123486